B2G Life Sciences
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B2G Life Sciences

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Based both in Paris (France) and Tunis (Tunisia), B2G Life Sciences is a CRO specialized in clinical and pharmaceutical development.

Based both in Paris (France) and Tunis (Tunisia), B2G Life Sciences is a CRO specialized in clinical and pharmaceutical development.

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B2G Life Sciences B2G Life Sciences Document Transcript

  • Building bridges and gateways
  • ďŽƵƚ hƐϮ >ŝĨĞ ^ĐŝĞŶĐĞƐ ŝƐ Ă ĐŽŶƐƵůƟŶŐ ĐŽŵƉĂŶLJ ĂŶĚ Ă ĐŽŶƚƌĂĐƚ ƌĞƐĞĂƌĐŚ ŽƌŐĂŶŝnjĂƟŽŶĚĞĚŝĐĂƚĞĚ ƚŽ ƚŚĞ ƉŚĂƌŵĂĐĞƵƟĐĂů ŝŶĚƵƐƚƌLJ͕ ƐƉĞĐŝĂůŝnjĞĚ ŝŶ ĐůŝŶŝĐĂů ĚĞǀĞůŽƉŵĞŶƚ͕ƉŚĂƌŵĂĐĞƵƟĐĂů ĚĞǀĞůŽƉŵĞŶƚ ĂŶĚ ƌĞŐƵůĂƚŽƌLJ ĂīĂŝƌƐ͘It is present both in Paris and Tunis.Three missions are developed:ඵ ŽŶƐƵůƟŶŐ ŝŶ ŵĞĚŝĐĂů ĂīĂŝƌƐ ĂŶĚ ĐůŝŶŝĐĂů ĚĞǀĞůŽƉŵĞŶƚ ĚŝƌĞĐƚĞĚ ƚŽǁĂƌĚƐ ƉŚĂƌŵĂĐĞƵƟĐĂůŝŶĚƵƐƚƌLJ ĂƐ ǁĞůů ĂƐ ƌĞƐĞĂƌĐŚ ŽƌŐĂŶŝnjĂƟŽŶƐ͕ ďĞ ƚŚĞLJ ƉƵďůŝĐ Žƌ ƉƌŝǀĂƚĞ͕ ǁŝƚŚ ĂƉĂƌƟĐƵůĂƌ ĞdžƉĞƌƟƐĞ ŝŶ ƚŚĞ ĮĞůĚ ŽĨ ďŝŽƚĞĐŚŶŽůŽŐLJ ƉƌŽĚƵĐƚƐ Žƌ ĂĚǀĂŶĐĞĚ ƚŚĞƌĂƉŝĞƐ͘ඵ Conduct and support of clinical trials in Europe and North Africa.ඵ ĞǀĞůŽƉŵĞŶƚ ŽĨ ƐĐŝĞŶƟĮĐ ĂŶĚ ƚĞĐŚŶŽůŽŐŝĐĂů ƉĂƌƚŶĞƌƐŚŝƉƐ ďĞƚǁĞĞŶ ƵƌŽƉĞ ĂŶĚEŽƌƚŚ ĨƌŝĐĂŶ ĐŽƵŶƚƌŝĞƐ ŝŶ ƚŚĞ ŵĞĚŝĐĂů ĂŶĚ ƉŚĂƌŵĂĐĞƵƟĐĂů ĮĞůĚ͘<ŶŽǁůĞĚŐĞ ŽĨ ƐĐŝĞŶĐĞ ĂŶĚ ŝŶĚƵƐƚƌLJ ĞŶǀŝƌŽŶŵĞŶƚƐ ŝŶ ďŽƚŚ ƵƌŽƉĞ ĂŶĚ EŽƌƚŚ ĨƌŝĐĂĂůůŽǁƐ ƵƐ ƚŽ ĂƐƐŝƐƚ ŝŶ ƚŚĞ ŝŵƉůĞŵĞŶƚĂƟŽŶ ŽĨ ŐĂƚĞǁĂLJƐ ĂŶĚ ŝŶƚĞƌĨĂĐĞƐ ĨŽƌ ĐŽŵŵƵŶŝĐĂƟŽŶďĞƚǁĞĞŶ ƚŚĞ ŶĞĞĚƐ ŽĨ ŽƉĞƌĂƚŽƌƐ ŝŶ ƚŚĞ ŝŶĚƵƐƚƌLJ ;ƉŚĂƌŵĂĐĞƵƟĐĂůĐŽŵƉĂŶŝĞƐ͕ ďŝŽƚĞĐŚƐ͕ ZKƐͿ ĂŶĚ ƚŚĞ ŵĞĚŝĐĂů͕ ƐĐŝĞŶƟĮĐ ĂŶĚ ĞĐŽŶŽŵŝĐ ƉŽƚĞŶƟĂůƐ ĞdžŝƐƟŶŐin North African countries. ZĞŐĂƌĚŝŶŐ dƵŶŝƐŝĂ dƵŶŝƐŝĂ ʹ ǁŚŝĐŚ ĐĂŶ ďĞ ƌĞŐĂƌĚĞĚ ĂƐ Ă ΗĨŽŽƚŚŽůĚΗ ĨŽƌ the development of clinical research in North Africa ʹ ĞŶũŽLJƐ Ă ŐŽŽĚ ƌĞƉƵƚĂƟŽŶ ĨŽƌ ƚŚĞ ƋƵĂůŝƚLJ ŽĨ ŝƚƐ ŵĞĚŝĐŝŶĞ͕ ƉĂƌƟĐƵůĂƌůLJ ĨƌŽŵ ƵƌŽƉĞĂŶ ƉƌŽĨĞƐƐŝŽŶĂůƐ ;ĚŽĐƚŽƌƐ ĂƐ ǁĞůů ĂƐ ĂƵƚŚŽƌŝƟĞƐͿ͘ /ŶŐƌĞĚŝĞŶƚƐ ŶĞĞĚĞĚ ĨŽƌ ƚŚĞ ŝŵƉůĞŵĞŶƚĂƟŽŶ ŽĨ Ă ĐůŝŶŝĐĂů ƌĞƐĞĂƌĐŚ are already in place: ඵ ŽŵƉĞƚĞŶƚ ŵĞĚŝĐĂů ĂŶĚ ƉŚĂƌŵĂĐĞƵƟĐĂů ƉĞƌƐŽŶŶĞů͕ Ă ůĂƌŐĞ ƉĂƌƚ ŽĨ ǁŚŝĐŚ ƚƌĂŝŶĞĚ ŝŶ ƵƌŽƉĞ Žƌ ŝŶ ƚŚĞ hŶŝƚĞĚ ^ƚĂƚĞƐ͖ ඵ džŝƐƚĞŶĐĞ ŽĨ Ă ůŽĐĂů ƉŚĂƌŵĂĐĞƵƟĐĂů ŝŶĚƵƐƚƌLJ ĂŶĚ ƉƌĞƐĞŶĐĞ ŽĨ ƚŚĞ ƚŽƉ ƉŚĂƌŵĂĐĞƵƟĐĂů ůĂďŽƌĂƚŽƌŝĞƐ͖ ඵ Favorable experiences of several medical teams in clinical research (Neurology, cancer diseases, Pediatrics, cardiology, respiratory diseases, etc.); ඵ Existence of a dynamic policy of encouraging ƐĐŝĞŶƟĮĐ ĂŶĚ ŵĞĚŝĐĂů ƌĞƐĞĂƌĐŚ͘ dŚĞ ƐĞĐƚŽƌ ŝƐ ƐĞƚ ƚŽ ŐƌŽǁ ĚƵĞ ƚŽ ŝƚƐ ŵĞĚŝĐĂů ĂŶĚ ĞĐŽŶŽŵŝĐ ƉŽƚĞŶƟĂů ďĞŶĞĮƚƐ͘ ඵ džŝƐƚĞŶĐĞ ŽĨ ĐůŝŶŝĐĂů ƌĞƐĞĂƌĐŚ ƌĞŐƵůĂƟŽŶƐ
  • ^ĞƌǀŝĐĞƐ KīĞƌĞĚ Ϯ >ŝĨĞ ^ĐŝĞŶĐĞƐ ŽīĞƌƐ ƚŚĞ ĨŽůůŽǁŝŶŐ ƐĞƌǀŝĐĞƐ͗ ඵ ŽƵŶƐĞůŝŶŐ ŝŶ ŵĞĚŝĐĂů ĂīĂŝƌƐ ĂŶĚ ĐůŝŶŝĐĂů ĚĞǀĞůŽƉŵĞŶƚ͘ ඵ /ŶǀĞƐƟŐĂƚŽƌ ƐŝƚĞƐ ŝĚĞŶƟĮĐĂƟŽŶ ĂŶĚ ƐĞůĞĐƟŽŶ͕ ĂƐ ǁĞůů ĂƐ ĐůŝŶŝĐĂů feasibility studies. ඵ Clinical protocol design. ඵ WƌĞƉĂƌĂƟŽŶ ŽĨ ĐůŝŶŝĐĂů ĚŽĐƵŵĞŶƚƐ ŶĞĞĚĞĚ ĨŽƌ ĐůŝŶŝĐĂů ƚƌŝĂů ĂƵƚŚŽƌŝnjĂƟŽŶ ;d Ϳ ƐƵďŵŝƐƐŝŽŶƐ͗ ĐůŝŶŝĐĂů ƉƌŽƚŽĐŽů͖ ƉĂƟĞŶƚ ŝŶĨŽƌŵĂƟŽŶ ŶŽƚĞƐ ĂŶĚ ĐŽŶƐĞŶƚ ĨŽƌŵƐ͖ ŝŶǀĞƐƟŐĂƚŽƌΖƐ ďƌŽĐŚƵƌĞ͖ ĐĂƐĞ ƌĞƉŽƌƚ ĨŽƌŵƐ ;Z&Ϳ͘ ඵ Clinical trial management. ඵ Clinical Trial Monitoring. ඵ DĂŶĂŐĞŵĞŶƚ ŽĨ ĂƚĂ DŽŶŝƚŽƌŝŶŐ ŽĂƌĚƐ ĂŶĚͬŽƌ ^ƚĞĞƌŝŶŐ ŽŵŵŝƩĞĞƐ during clinical trials. ඵ Pharmacovigilance. ඵ dƌĂŝŶŝŶŐ ŝŶ ƚŚĞ ďƵƐŝŶĞƐƐĞƐ ŽĨ ĐůŝŶŝĐĂů ĚĞǀĞůŽƉŵĞŶƚ͗ ŽŽĚ ůŝŶŝĐĂů WƌĂĐƟĐĞ (ICH-GCP), project management. ඵ ŽƵŶƐĞůŝŶŐ ŽŶ ZĞŐƵůĂƚŽƌLJ īĂŝƌƐ ĂŶĚ d ƐƵďŵŝƐƐŝŽŶ͘ ඵ ŽƵŶƐĞůŝŶŐ ĂŶĚ ƐĞƌǀŝĐĞƐ ŝŶ ƉŚĂƌŵĂĐĞƵƟĐĂů ĚĞǀĞůŽƉŵĞŶƚ (galenic development and bioequivalence) ඵ WŚĂƌŵĂĐĞƵƟĐĂů ƚƌĂĚŝŶŐdžƉĞƌŝĞŶĐĞ Θ džƉĞƌƟƐĞB2G Life Sciences capitalizes on the experience of its founder, Dr. Hafedh HADDAD.&ŽƌŵĞƌ ,ĞĂĚ ŽĨ ůŝŶŝĐĂů ĞǀĞůŽƉŵĞŶƚ Ăƚ ĞŶĞƚŚŽŶ ; ůĞĂĚĞƌ &ƌĞŶĐŚ ŝŽƚĞĐŚ ŝŶ ƚŚĞ ĮĞůĚ ŽĨadvanced therapies), Dr. Haddad is a Medical Doctor and holds a Master Degree in ClinicalResearch (FIEC), from the University Pierre et Marie Curie – Paris VI.EĞƵƌŽůŽŐLJ͖ ŚĞŵĂƚŽůŽŐLJ͖ ĚĞƌŵĂƚŽůŽŐLJ͖ ŽƉŚƚŚĂůŵŽůŽŐLJ͖ ƌĂƌĞ ĂŶĚ ŐĞŶĞƟĐ ĚŝƐĞĂƐĞƐ͖ŽďƐĞƌǀĂƟŽŶĂů ƐƚƵĚŝĞƐ͖ ďŝŽƚĞĐŚŶŽůŽŐLJ ƉƌŽĚƵĐƚƐ͖ ĂĚǀĂŶĐĞĚ ƚŚĞƌĂƉŝĞƐ͖ ƉĞƌƐŽŶĂůŝnjĞĚ ŵĞĚŝĐŝŶĞ͖biosimilars; galenic development; bioequivalence;ĐůŝŶŝĐĂů ĚĞǀĞůŽƉŵĞŶƚ͖ ƉŚĂƌŵĂĐĞƵƟĐĂů ĚĞǀĞůŽƉŵĞŶƚ͘
  • b2gls.com Contact: 14 Rue charles V 75004 Paris - France b2gls@b2gls.com Tel.: +33 (0)9 70 40 76 09 CEO & Medical Director: ,ĞĂĚ ŽĨ ZĞŐƵůĂƚŽƌLJ īĂŝƌƐ Θ WŚĂƌŵĂĐĞƵƟĐĂů ĞǀĞůŽƉŵĞŶƚ Hafedh HADDAD, MD hafedh.haddad@b2gls.com Sonia Elkara, Pharm D sonia.elkara@b2gls.comMobile Paris: +33 (0)6 15 47 72 77 Mobile Tunis: +216 21 79 53 20 Mobile Tunis: +216 25 263 739